Drug-eluting balloon versus bare-mental stent and drug-eluting stent for de novo coronary artery disease: A systematic review and meta-analysis of 14 randomized controlled trials.

Kongyong Cui,Jing Dai,Fei Yuan,Min Zhang,Shuzheng Lyu,Xiantao Song,Wei Wang,Dongfeng Zhang,Feng Xu,Raffaele Bugiardini

doi:10.1371/journal.pone.0176365

Kongyong Cui, Jing Dai + Show 8 more

Open Access

https://doi.org/10.1371/journal.pone.0176365

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Journal: PloS one	Publication Date: Apr 26, 2017
Citations: 10	License type: CC BY 4.0

Affiliation: Beijing Anzhen Hospital, Capital Medical University

Abstract

BackgroundDrug-eluting balloon (DEB) has become an alternative option to drug-eluting stent (DES) for the treatment of in-stent restenosis (ISR). However, the effect of drug-eluting balloon with regular bare-mental stent (BMS) in de novo coronary artery disease (CAD) is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD.MethodsRandomized controlled trials (RCTs) assessing the efficacy of DEB+BMS in comparison with BMS or DES were obtained by searching the PubMed, EMBASE, and Cochrane Library databases through January 2016. Primary endpoints were major adverse cardiac events (MACEs) and late lumen loss (LLL). Secondary endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis (ST), binary restenosis, and minimum lumen diameter (MLD). Dichotomous and continuous data were presented as odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs), respectively, and analyzed using a random-effects model.ResultsA total of 14 RCTs involving 2281 patients were included in this meta-analysis. DEB+BMS showed significantly less MACEs (OR: 0.67, 95%CI 0.45 to 0.99, P = 0.04) and reduced LLL (MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001) compared with BMS. Meanwhile, treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95%CI 1.24 to 3.05, P = 0.004), LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003), TLR (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003), and MLD (MD: -0.25 mm, 95%CI: -0.42 mm to -0.09 mm, P = 0.003).ConclusionsThis limited evidence demonstrated that treatment with DEB+BMS appears to be effective in de novo CAD. In addition, DEB+ BMS clearly showed superiority to BMS, but is inferior to DES in the treatment of patients with de novo CAD. Hence, DES (especially new generation DES) should be recommended for patients with de novo CAD.

Highlights

First-generation drug-eluting stents (DESs) reduce restenosis after percutaneous coronary intervention (PCI) by preventing vessel wall recoil and late negative remodeling, as well as restraining neointimal hyperplasia [1,2]
drug-eluting balloon (DEB)+bare-mental stent (BMS) showed significantly less major adverse cardiac events (MACEs) (OR: 0.67, 95%confidence intervals (CIs) 0.45 to 0.99, P = 0.04) and reduced late lumen loss (LLL) (MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001) compared with BMS
Treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95% CI 1.24 to 3.05, P = 0.004), LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003), target lesion revascularization (TLR) (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003), and minimum lumen diameter (MLD) (MD: -0.25 mm, 95%CI: -0.42 mm to -0.09 mm, P = 0.003)

Summary

Introduction

First-generation drug-eluting stents (DESs) reduce restenosis after percutaneous coronary intervention (PCI) by preventing vessel wall recoil and late negative remodeling, as well as restraining neointimal hyperplasia [1,2] They are associated with many potential serious complications such as late stent thrombosis, non-homogenous drug delivery, and delayed vascularization, which makes bare-mental stent (BMS) preferred with shorter dual antiplatelet therapy in patients at high bleeding risk [3,4]. The effect of drug-eluting balloon with regular bare-mental stent (BMS) in de novo coronary artery disease (CAD) is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD.

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Conclusion